DUPHASTON

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DYDROGESTERONE

Available from:

ABBOTT MEDICAL LABORATORIES LTD, ISRAEL

ATC code:

G03DB01

Pharmaceutical form:

FILM COATED TABLETS

Composition:

DYDROGESTERONE 10 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ABBOTT HEALTHCARE PRODUCTS B.V., NETHERLANDS

Therapeutic group:

DYDROGESTERONE

Therapeutic area:

DYDROGESTERONE

Therapeutic indications:

Cases where progesterone supplement is needed.

Authorization date:

2023-10-31

Summary of Product characteristics

1
DUPHASTON
FILM COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Duphaston
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg dydrogesterone.
Excipient with known effect: 111.1 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
A round, biconvex, white film-coated tablet, (with a diameter of 7 mm)
with a score line,
with the inscription ‘155’ on both sides of the score line.
The score line is only to make the tablet easier to break so that it
is easier to swallow; it is not
intended for dividing it into equal doses.
4.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
4.1
Cases where progesterone supplement is needed.
POSOLOGY AND METHOD OF ADMINISTRATION
4.2
Posology
The following dosage regimens are recommended for treatment with
Duphaston. The
quantities can be adjusted according to the seriousness of the
disorder to be treated and the
individual patients’ responses to the treatment.
_Regulation of the cycle _
It is possible to achieve a cycle lasting 28 days by giving 1 tablet
of Duphaston a day from
the 11
th
to the 25
th
day of the cycle.
_Endometriosis _
1 to 3 tablets of Duphaston a day from the 5
th
to the 25
th
day of the cycle or for the entire
cycle. Dosages of 10 mg several times a day should be spread over the
day. It is
recommended to start treatment with the highest dosage.
_ _
_Dysmenorrhoea _
1 to 2 tablets of Duphaston a day from the 5
th
to the 25
th
day of the cycle. Dosages of 10 mg
several times a day should be spread over the day. It is recommended
to start the treatment
with the highest dosage.
_Infertility as a result of corpus luteum insufficiency _
1 tablet of Duphaston a day from the 14
th
to the 25
th
day of the cycle.
2
Treatment should be continued for at least 6 consecutive cycles. It is
advisable to continue
this treatment for the first months of any pregnancy at dosages as
indicated for habitual
abortion.
_Luteal support as part of an Assisted Reproductive Technology (ART)
treatment _
1 tablet of Duph